DDS-ZR

K041645 · Charles Scharf · EIH · Jul 9, 2004 · Dental

Device Facts

• Record ID: K041645
• Device Name: DDS-ZR
• Applicant: Charles Scharf
• Product Code: EIH · Dental
• Decision Date: Jul 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, V (Inlays and Onlays) and as a restorative material intended for veneers, crowns, and bridges

Device Story

DDS-ZR is a zirconia hybrid ceramic restorative material used to fabricate dental restorations including crowns, bridges, inlays, and onlays. The dental professional prepares the tooth, takes an impression, and sends it to a laboratory. The laboratory uses computer-aided machining to produce the restoration from the zirconia material. The finished restoration is returned to the dentist for permanent placement using traditional luting or cementing techniques. The material is radioopaque for visualization. It serves as an alternative to gold, amalgam, porcelain, or composite filling materials. The device is used in a clinical dental setting by dental professionals to restore tooth structure and function, potentially benefiting the patient by providing a durable, biocompatible, and aesthetic restorative solution.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by the known biocompatibility of zirconia and its established history of use in dental and medical applications, as well as comparison to legally marketed predicate devices.

Technological Characteristics

Zirconia hybrid ceramic material; radioopaque; form factor suitable for computer-aided machining (CAD/CAM) of dental restorations. Biocompatible material. No specific software algorithm or energy source described for the material itself.

Indications for Use

Indicated for patients requiring restoration of carious lesions or structural defects in teeth, specifically for Class I, II, and V cavities (inlays and onlays), as well as veneers, crowns, and bridges.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Predicate Devices

• Cercon (K013230)
• Cynovad Zirkon (K023327)
• Denzir (K984201)

Submission Summary (Full Text)

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## XI. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. October 8, 1998. [Separate Pages]

Submitter: Chris Scharf, DDS Services, 7375 S. Peoria, #105, Englewood, CO 80112

- Classification names and numbers: Porcelain powder for clinical use, 76EIH, I. Class II.
- Dental restorative material, porcelain powder/blocks Common/Usual name: II.
- Proprietary name: DDS-ZR III.
- Establishment registration number: In process IV.
- These are class II devices, material restoratives, for the Classification: V. Classification:
purpose of computer machining dental restorations (Crowns, Bridges, Inlays, and Onlays) per CFR 872.6660
- DDS-ZR is a Zirconia hybrid ceramic ideally suited for Device description: VI. Device description: - DDD DR is oplications. The dental professional prepares the computerized demail macinning "Fraditionally prepared impression to the lab appropriate tooth burroduced, computer machined, and then returned to the where for placement. The dentists practice traditional luting/cementing techniques to permanently place the inlay or onlay. DDS-ZR is an alternative to gold, amalgam, porcelain, or composite filling materials, except that its gold, amargain; porcelain, or vobles gold inlays or porcelain inlays or veneers in application more closery resed in a dental laboratory. The material is radioopaque, for ready visualization.
- Similar to devices currently on the market approved Substantial equivalence: VII. Substantial equivalencer.
through the 510K process. DDS-ZR is similar to Cercon K-013230, Cynovad Zirkon K023327, and Denzir K984201.

The 510K "Substantial equivalence" decision-making process (detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

- These products have the same intended use, to be luted/cemented permanently 1. into place as inlays, and Onlays.
- 2. The technological characteristics for this product are similar to those for the I no teentiers and those currently on the market except for differences in prodicals of use. The technological features, although distinct, have the same intended use as the devices listed as equivalent.

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- 3. Descriptive information provided shows that the material from which DDS-Descriptive information pro Auss of many different kinds of hip EN are made are well colacinely greater forces than in the mouth.
- 4. Zirconia has been repeatedly tested throughout the medical and dental Zircoma has been repoatedry tential and be highly biocompatible. The nitusity and research has all his summary are traditional materials well known to the dental industry.

(End of Summary)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2004

Charles Scharf C/O Mr. Chris Scharf FDA Correspondent DDS Services, Incorporated 7375 South Peoria, #105 B-10 Englewood, Colorado 80112

Re: K041645

Trade/Device Name: DDS-ZR Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 10, 2004 Received: June 17, 2004

Dear Mr. Scharf:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Scharf

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements mean that I Dr man made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal but is requirements, including, but not limited to: registration 1 ou intist compry with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF Real von), e quality systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form nroduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This loter will and in your finding of substantial equivalence of your device to a premarket notification. - 11 miles results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire speoffice of Compliance at [phone]. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Carls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K041645

510(k) Number (if known):_

DDS-ZR Device Name: Indications for Use:

Intended to restore carious lesions or structural defects in teeth. It is
t and and and constitues Charact III. V (Inlays and Onlays) and a Intended to restore callous lesions of Structures and Onlays and as a
intended for use in cavities Classes I, II, V (Inlays and Onlays) and hiddes intended for use in Cavitles Glassoc i, m, o (1) = (1) = (1) = (1) = (1) = )
restorative material intended for veneers, crowns, and bridges

AND/OR Prescription Use ____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chris

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K041645

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